- Approved for use in the treatment of patients with metastatic breast cancer whose tumors substantially over express the HER2 protein
- Investigational in children (Phase II) as adjunctive immunotherapy for metastatic osteosarcoma over expressing HER2
- Available as a freeze-dried powder at 440 mg per vial
- Reconstitute with 20 mL of Bacteriostatic Water for Injection (BWFI), supplied, to give a final concentration of 21 mg/mL. Swirl gently. DO NOT SHAKE SOLUTION.
- Reconstituted solution should be clear to slightly opalescent, and colorless to pale yellow
- Solution reconstituted with BWFI is stable for 28 days in the refrigerator
- DO NOT FREEZE reconstituted solution
- Dilute further in 250 mL NS to administer IV. Mix by inverting bag gently to avoid foaming.
- Diluted solutions stable 24 hours at room temperture. Refrigerate to avoid bacterial contamination.
- Solutions Compatibe: NS. DO NOT USE D5W.
- No other compatibility known. Run in dedicated line.
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|IV Intermittent Infusion||
|IV Continuous Infusion||NO|
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- For COG protocol AOST0121, 4 mg/kg week 1, then 2 mg/kg weekly for a further 33 weeks (total of 34 weekly doses)
- Give prior to the start of chemotherapy
** Dosage may differ according to protocol
- Common: fever, chills, rigors, nausea, vomiting, headache, rash, asthenia, pain at tumor site, diarrhea
- Occasional: flu-like syndrome - paresthesias, bone pain, arthralgias
- Rare: hypotension; anaphylaxis; ARDS; bronchospasm; dyspnea; death from allergic, pulmonary, or infusion reactions
- Treatment for unusual side effects are available through the study chair identified on the front of the protocol and/or pharmacy
- Infusion requires 1:1 nursing, with vital signs (BP, HR, RR, TºC) monitoring every 15 minutes during infusion and for 60 minutes post-infusion
- Have anaphylaxis kit available at bedside
- Premedication with acetaminophen, antihistamine, or steroid may be required depending on tolerance